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FDA 510(k)

SMAC SYS., SUPPLEMENTAL PRODUCTS FOR

K-Number: K771033 · 1977-08-04

ApplicantMid Tech, Inc.
Decision Date1977-08-04
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMAC SYS., SUPPLEMENTAL PRODUCTS FOR is the device name listed in this FDA 510(k) record. The listed applicant is Mid Tech, Inc.. It received FDA 510(k) clearance on 1977-08-04 under 510(k) number K771033. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMAC SYS., SUPPLEMENTAL PRODUCTS FOR?

SMAC SYS., SUPPLEMENTAL PRODUCTS FOR is a medical device that received FDA 510(k) clearance on 1977-08-04. The listed applicant is Mid Tech, Inc.. The 510(k) number is K771033.

When did SMAC SYS., SUPPLEMENTAL PRODUCTS FOR receive FDA 510(k) clearance?

SMAC SYS., SUPPLEMENTAL PRODUCTS FOR received FDA 510(k) clearance on 1977-08-04, under 510(k) number K771033.

Who is the listed applicant for SMAC SYS., SUPPLEMENTAL PRODUCTS FOR?

The FDA 510(k) record lists Mid Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMAC SYS., SUPPLEMENTAL PRODUCTS FOR?

The FDA product code for SMAC SYS., SUPPLEMENTAL PRODUCTS FOR is CKA.

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Other records listing Mid Tech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K810951REAGENTS FOR QUANT. ENZYMATIC DETER.-TR.K791869GLUCOSE OXIDASE (FRINDER) KITK791313ARS, CHEMISTRYK770508SMAC SYSTEM

Related Devices (Code: CKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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